Actively Recruiting
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Led by Duke University · Updated on 2025-08-19
76
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how inspiratory muscle dysfunction (IMD) and small airway dysfunction (SAD) contribute to asthma in lean and obese children aged 6 to 17 with moderate to severe asthma. This study aims to compare these respiratory issues between children with obesity-related asthma and those without obesity. The research includes a randomized, sham-controlled trial to evaluate the effects of inspiratory training (IT) on these lung functions. Participants will be assigned to one of three groups: a sham control group or one of two active inspiratory muscle rehabilitation groups using a PrO2™ device. The device provides resistance during breathing exercises at three intensity levels—low dose (40% of maximum inspiratory pressure, MIP), high dose (75% of MIP), and sham (15% of MIP). Training lasts 8 weeks, with participants doing 150 inspirations three times per week, using a Bluetooth-connected device and app that monitor adherence and provide real-time feedback. Over the 10-week participation period, children will undergo detailed assessments of respiratory mechanics and muscle function at baseline and after training. Researchers will measure outcomes such as the number of participants with IMD and SAD in both obese and non-obese groups, and inspiratory muscle endurance. The study carefully monitors adherence and uses statistical methods to compare results, considering factors like age, sex, race, asthma severity, and allergies.
CONDITIONS
Brief Title
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 17 years
- Clinician-diagnosed asthma
- Requires two or more controller medications for asthma treatment
- Body mass index (BMI) either in the normal range (5th to 84th CDC percentile) or classified as obese (95th percentile BMI up to less than 170% of the 95th CDC percentile)
You will not qualify if you...
- Asthma Control Test (ACT) score less than 17
- History of intubation for asthma
- Forced expiratory volume in 1 second (FEV1) less than 50% of predicted at enrollment
- Currently pregnant
- Legal guardian unable to consent in English or Spanish
- Any major chronic illness interfering with participation as judged by the principal investigator
- Younger than 6 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants use the PrO2™ device for inspiratory muscle training at assigned resistance levels to improve inspiratory muscle function and small airway measures.
Baseline evaluation visit and 1 visit at 8 weeks
Trial Site Locations
Total: 2 locations
1
Duke Health Center Creekstone
Durham, North Carolina, United States, 27703
Actively Recruiting
2
Duke Healthy Lifestyles Clinic
Durham, North Carolina, United States, 27704
Actively Recruiting
Research Team
J
Jason Lang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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